Background

Protech Pharmaservices Corporation (PPC) was founded in 1997 to meet the growing demands for R&D outsourcing from the Pharmaceutical and Biotech industries in the Asia- Pacific region. PPC is the largest CRO in Taiwan to offer a complete range of Clinical Research and Contract Laboratories services. In order to build up an international CRO network, PPC has formal alliances in Japan. In addition, PPC has branch operations in China (Beijing, Shanghai), Japan, and Korea.

About the Job We are looking for (Senior) Biostatistician in PPC Shanghai office. As a (Senior) Biostatistician, you are responsible for providing statistical services on Phase I-IV clinical trials, including but not limited to the responsibilities below:

• Assist with protocol development, sample size calculation, protocol and case report form (CRF) review
• Advise data management staff on database design, and be responsible for critical data and data quality review
• Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule)
• Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups
• SAS programming and related activities for the presentation and analysis of clinical trial data
• Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding
• Responsible for statistical input to statistical reports and Clinical Study Reports
• Understand the submission issues, having the ability to communicate with experts in CDE in an effective manner
• Support of Business Development, e.g. by attending and preparing bid defense meetings
• Interact with clients as key contact with regard to statistical and contractual issues
• Provide consulting services in statistical field, which includes but not limited to study design interpretation, problem-solving in implementation, data-examination guidance and research-result explanation

Education/Qualifications

• PhD or Master in statistics/biostatistics, mathematics, epidemiology, or other related data science majors
• Good communication skills and ability in building sound relationships
• Good collaboration with colleagues, working in a high efficient and cross-functional manner
• Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH-GCP etc.)
• A good understanding of statistical issues in clinical trials
• Understand and apply moderately advanced statistical methods
• Ability to work independently

上班地址：新天地中海国际中心（地铁1，9、10、13号线）